UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045792 |
|---|---|
| Receipt number | R000052282 |
| Scientific Title | Clinical validity of mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/10/21 19:36:35 |
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Basic information
Public title
Clinical validity of mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer
Acronym
Mutated DNA monitoring in plasma and urinary pellet in the recurrent diagnosis of bladder cancer
Scientific Title
Clinical validity of mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer
Scientific Title:Acronym
Mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To verify the clinical validity of specific mutations in plasma and urinary pellet DNA as a recurrence evaluation after bladder cancer surgery by analyzing tumor.
Basic objectives2
Others
Basic objectives -Others
Clinical validity of ctDNA as tumor marker in terms of early relapse prediction, treatment evaluation, and non-relapse corrboration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic lead time(day precedes relapse diagnosis by imaging modalities)
Key secondary outcomes
Decrease of plasma and urinary pellet VAF or disappearance of mutant alleles in recurrence-free cases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who have agreed to participate in the research
2) Cases in which TUR-Bt is performed for high-risk bladder cancer (multiple, recurrence, T1 or higher, high grade, including CIS, etc.), or within 2 years after the operation
3) Histological diagnosis of urothelial cancer
4) Expected life expectancy is 6 months or more
5) With or without additional postoperative therapy (2nd TUR-Bt, BCG therapy, chemotherapy, total cystectomy)
6) Regardless of recurrence / regrowth and treatment status at the start of blood collection
7) Regardless of age, gender, performance states, etc.
Key exclusion criteria
1) Patients who have difficulty in outpatient visits
2) Patients with psychiatric symptoms who have difficulty participating in the study
3) Patients with serious complications
4) Patients judged by the principal investigator to be inappropriate for registration
5) Cases in which pathological diagnosis and sequence analysis cannot be compatible due to the small amount of tumor sample
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nishizuka |
| Middle name | |
| Last name | Satoshi |
Organization
Iwate Medical University Institute for Biomedical Sciences
Division name
Division of Biomedical Research and Development
Zip code
028-3695
Address
1-1-1 Idaidori, Yahaba, Iwate
TEL
019-651-5111
snishizu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Abe |
Organization
Iwate Medical University Institute for Biomedical Sciences
Division name
Division of Biomedical Research and Development
Zip code
028-3695
Address
1-1-1 Idaidori, Yahaba, Iwate
TEL
019-651-5111
Homepage URL
amasa@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University Institute for Biomedical Sciences Division of Biomedical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for scientific research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Iwate Medical University
Address
2-1-1 Idaidori, Yahaba, Iwate
Tel
019-613-7111
kenkyu-rinri@j.iwate-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://nishizukalab.org/protocol.html
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
33
Results
Most (30/32; 93.8%) cases showed at least one traceable somatic mutation. In 5 of 7 (71.4%) cases with clinical recurrence, upDNA VAF >1% was detected 7-15 months earlier than the imaging diagnosis. The upDNA VAF remained high after initial treatment for locally recurrent cases. The clinical validity of upDNA monitoring was confirmed with the observation that 26 of 30 (86.7%) cases were traceable.
Results date posted
| 2023 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Previously treated and untreated patients with bladder cancer.
Participant flow
Somatic mutations were identified from bladder cancer samples using a panel sequence. The most recent FFPE tumor specimen was selected for previous treatment cases, and the transurethral resection of bladder tumor (TURBT) specimen at enrollment was selected for initial treatment cases. Plasma and urine samples were collected in the monitoring of the day of surgery and once on day 1-3 postoperatively. The clinical course along with VAF dynamics of circulating tumor DNA (ctDNA) and urinary pellet DNA (upDNA) were analyzed for all eligible cases for up to 2 years.
Adverse events
None
Outcome measures
(a) at least two consecutive positive time points (TP) before diagnosis of clinical recurrence; (b) VAF decreased after treatment; and (c) negative and no clinical recurrence for at least one year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Relationship between clinical recurrence diagnosis and detection of mutant alleles in plasma and urinary pellet
Management information
Registered date
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052282
